The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

Philip Kern

Status and phase: Enrolling; Phase 4

Conditions: Pre-diabetes; Obesity

Treatments: Drug: Placebo; Drug: Mirabegron 50 MG; Drug: Tadalafil 10 MG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05051436

R01DK128033 (U.S. NIH Grant/Contract)

55665

Details and patient eligibility

About

The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.

Enrollment: 96 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hemoglobin A1C between 5.7 and 6.4
• Body mass index between 27 and 45

Exclusion criteria

• Diabetes
• Chronic use of any antidiabetic medications
• Any unstable medical condition
• Use of steroids or daily use of NSAIDS
• History of chronic inflammatory conditions
• Use of anticoagulants
• Contraindications to the use of mirabegron or tadalafil
• Any condition deemed risky by the study physician

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 4 patient groups, including a placebo group

Mirabegron (M)

Experimental group

Description:

Drug will be administered for 12 weeks after baseline procedures.

Treatment:

Drug: Mirabegron 50 MG

Tadalafil (T)

Experimental group

Description:

Drug will be administered for 12 weeks after baseline procedures.

Treatment:

Drug: Tadalafil 10 MG

Mirabegron and Tadalafil (MT)

Experimental group

Description:

Both drugs will be administered for 12 weeks after baseline procedures.

Treatment:

Drug: Tadalafil 10 MG

Drug: Mirabegron 50 MG

Placebo (P)

Placebo Comparator group

Treatment:

Drug: Placebo